Family Intervention for Black Teens With Type 1 Diabetes

(3Ms Trial)

Recruiting at 4 trial locations

Overseen By Jillian T Sjostrom, B.S.

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Wayne State University

Disqualifiers: Mental health, Cystic fibrosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

216 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called The 3Ms 2.0, designed to assist Black teens with type 1 diabetes and their families. The goal is to determine if this program can improve diabetes management in teens and strengthen family relationships. Participants will either receive The 3Ms 2.0, which includes mobile phone resources for parents, or educational materials as part of standard care. Teens aged 10 to 14 who have had type 1 diabetes for at least six months and live within 30 miles of a study site are eligible, provided their primary caregiver is also willing to participate. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance diabetes management and family support.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that The 3Ms 2.0 intervention is safe for Black teens with type 1 diabetes?

Research has shown that the 3Ms 2.0 program, designed for Black teens with type 1 diabetes and their caregivers, is easy to use and safe. In similar studies, using the program on mobile devices resulted in no reports of serious side effects. Caregivers and healthcare providers found the digital format both user-friendly and helpful. This suggests the program is safe for families managing diabetes care. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about The 3Ms 2.0 Intervention because it takes a family-centered approach to managing Type 1 Diabetes in Black teens, which is not typically emphasized in standard care options. Unlike conventional treatments that focus primarily on medical management through insulin therapy and glucose monitoring, this intervention aims to engage and educate the entire family to improve adherence and outcomes. By addressing cultural and familial dynamics, The 3Ms 2.0 Intervention has the potential to enhance support systems and improve long-term diabetes management for teens in a way that current treatments do not.

What evidence suggests that The 3Ms 2.0 Intervention is effective for improving glycemic control and family relationships in Black teens with type 1 diabetes?

Research shows that the 3Ms 2.0 program, which participants in this trial may receive, might help Black teens with Type 1 diabetes manage their condition better. An earlier study of the original 3Ms program found that teens managed their diabetes more effectively when their parents assisted with insulin doses and blood sugar checks. This new version of the program emphasizes building family support, which can reduce stress for both teens and their caregivers. By using mobile phones, 3Ms 2.0 facilitates family connection and involvement. Although more research is needed to confirm its effectiveness, early results suggest it could be a promising way to improve diabetes management. ^{1 2 3 5 6}

Who Is on the Research Team?

Deborah A Ellis, Ph.D.

Principal Investigator

Wayne State University

Are You a Good Fit for This Trial?

This trial is for Black adolescents with type 1 diabetes and their primary caregivers. Participants should be interested in improving blood sugar control and family relationships related to diabetes management. The study seeks families willing to use mobile health tools like video clips and text messages.

Inclusion Criteria

Black

I have been diagnosed with Type 1 diabetes.

Residence within 30 miles of a recruitment site

Exclusion Criteria

Mental health conditions that might compromise data integrity (e.g., developmental delay, schizophrenia, psychosis, current suicidality, homicidality)

I manage my diabetes differently due to another health condition.

Inability to speak or read English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive The 3Ms 2.0 intervention or Educational Attention Control over a six-month period

6 months

Sessions delivered via mobile device

Data Collection

Data collected at baseline, 3 months, 6 months, and 12 months post-baseline, including questionnaires and blood samples for HbA1c

12 months

4 data collection points (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

6 months

What Are the Treatments Tested in This Trial?

Interventions

• The 3Ms 2.0 Intervention

Trial Overview

The trial is testing 'The 3Ms 2.0 Intervention', a mobile health program designed to help manage type 1 diabetes, against an educational attention control group (EAC). It aims to see if the intervention can better support teens' blood sugar levels and reduce stress for caregivers.

How Is the Trial Designed?

Group I: The 3Ms 2.0 Intervention + Standard Medical Care Experimental Treatment 1 Intervention

Group II: Educational Attention Control (EAC) + Standard Medical Care Active Control 1 Intervention

Who Is Running the Clinical Trial?

Wayne State University

Lead Sponsor

Trials

318

Recruited

111,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Published Research Related to This Trial

Educational interventions for children with type 1 diabetes effectively improve diabetes knowledge but do not consistently lead to better metabolic control, based on a review of 41 studies published between 1980 and 1999.

Psychosocial interventions, particularly coping skills training and peer support, are beneficial for adolescents in improving their adjustment to diabetes and can sometimes enhance metabolic control, while family interventions help reduce conflicts between parents and children regarding diabetes management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interventions for children with diabetes and their families. Grey, M.[2019]

The TEAM pilot trial aims to enhance collaborative involvement in Type 1 diabetes management among African American and Latino parents of children aged 5-10, addressing significant health disparities in glycemic outcomes.

This randomized trial will assess the feasibility and acceptability of the TEAM intervention, while also examining its potential impact on children's HbA1c levels, treatment adherence, and overall quality of life compared to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-support intervention for African American and Latino parents to improve the glycemic control trajectory among school-aged children with type 1 diabetes: A pilot and feasibility protocol. Butler, AM., Hilliard, ME., Fegan-Bohm, K., et al.[2022]

In a study of 71 youth with type 1 diabetes, it was found that African American youth experienced a faster decline in metabolic control compared to White youth shortly after diagnosis, with significant differences in hemoglobin A1c levels observed by 24 months.

The study revealed that living in a single-parent household was a strong predictor of worsening metabolic control, with youth from single-parent families deteriorating almost three times faster than those from two-parent families, highlighting the need for targeted support interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting metabolic control in the first 5 yr after diagnosis for youths with type 1 diabetes: the role of ethnicity and family structure. Frey, MA., Templin, T., Ellis, D., et al.[2022]

Parenting interventions for caregivers of children with type 1 diabetes significantly reduce psychological distress and depression, as shown in a meta-analysis of 17 randomized controlled trials involving 962 participants.

These interventions also help parents seek positive social support, indicating that structured support can improve the mental well-being of caregivers managing diabetes in their children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Parenting Interventions on Psychosocial Adjustment in Parents of Children and Adolescents with Type 1 Diabetes: A Meta-Analysis. Zhao, X., Ai, Z., Chen, Y., et al.[2022]

The incidence of Type 1 diabetes (T1D) is increasing among youth, particularly in African-American children under 5, highlighting significant health disparities.

There is a notable gap between the demographics of children with T1D participating in research and those most affected, indicating a need for more inclusive and culturally appropriate study designs in behavioral interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considering Culture: A Review of Pediatric Behavioral Intervention Research in Type 1 Diabetes. Rose, M., Aronow, L., Breen, S., et al.[2019]

Multisystemic therapy (MST) significantly improved metabolic control in adolescents with chronic poor diabetes management, showing a 1.01% decrease at 7 months and a 0.74% decrease at 12 months compared to those receiving only telephone support.

Parents reported better adherence to diabetes management in their adolescents receiving MST, suggesting that this intensive, home-based approach can enhance family involvement and potentially improve health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multisystemic therapy compared to telephone support for youth with poorly controlled diabetes: findings from a randomized controlled trial. Ellis, DA., Naar-King, S., Chen, X., et al.[2022]

A pilot study involving 17 adolescents with poorly controlled type 1 diabetes showed significant improvements in blood glucose monitoring frequency and glycemic control after a 14-week motivational intervention that included family-based contingency management.

The adolescents' HbA1c levels improved significantly, indicating better diabetes management, which suggests that this multicomponent approach could be effective and warrants further testing in a randomized controlled trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A multicomponent motivational intervention to improve adherence among adolescents with poorly controlled type 1 diabetes: a pilot study. Stanger, C., Ryan, SR., Delhey, LM., et al.[2022]

A randomized clinical trial involving 67 African American adolescents with type 1 diabetes and their caregivers showed that a brief, computer-delivered motivational intervention significantly increased parents' knowledge about the importance of monitoring their child's diabetes management.

The intervention not only improved parental monitoring practices but also led to significant improvements in glycemic control among adolescents, highlighting its potential efficacy in enhancing diabetes management in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brief Computer-Delivered Intervention to Increase Parental Monitoring in Families of African American Adolescents with Type 1 Diabetes: A Randomized Controlled Trial. Ellis, DA., Idalski Carcone, A., Ondersma, SJ., et al.[2022]

A 2-year randomized clinical trial involving 390 families showed that a low-intensity, clinic-integrated behavioral intervention significantly improved glycemic control in youth with type 1 diabetes, particularly in those aged 12 to 14.

The intervention effectively prevented the typical decline in diabetes management during adolescence, suggesting it could be a valuable approach to integrate behavioral support into medical care for diabetes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinic-integrated behavioral intervention for families of youth with type 1 diabetes: randomized clinical trial. Nansel, TR., Iannotti, RJ., Liu, A.[2022]

Citations

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The 3Ms were as follows: (1) watch your child give as many doses of insulin each day as possible (Medicine), (2) check your child's blood glucose meter at least ...

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The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for ...

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Family Intervention for Black Teens With Type 1 Diabetes

The purpose of this study is to conduct a multicenter, randomized effectiveness trial of The 3Ms 2.0 compared to an educational control condition for ...

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cdn.clinicaltrials.gov/large-docs/67/NCT03168867/Prot_SAP_000.pdf

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The 3Ms intervention is designed to be delivered over nine months should families receive diabetes care at the recommended frequency.

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581-P: Implementing the 3Ms eHealth Intervention in Clinical ...

The present study explored caregivers' and health care providers' (HCP) impressions of The 3Ms, an eHealth intervention to improve parental ...